Quality Assurance Specialist

vor 2 Wochen

Lucerne, Schweiz Randstad (Schweiz) AG Vollzeit
Jobdescription

For our client, a pharmaceutical company based in Lucerne, we are looking for a Quality Assurance Specialist.

In this role the QA Specialist will review batch record of clinical supplies which are packaged locally and at CMO. This position offers a thrilling cross functional work environment with multiple stakeholders in multiple countries. 

General Information:

  • Start Date: ASAP
  • Duration: until 30.06.2025
  • Workload: 100%
  • Workplace: Lucerne

Responsibilities include but are not limited to:

  • Review and release of incoming label stock
  • Review, and release of clinical finished goods, including review of the printed and applied label
  • GMP review of the batch record and review of the regulatory filings and the final release
  • Collaborate closely with our internal functional areas (i.e. GMP Manufacturing & Packaging & Logistics, Comparator Planning, Clinical Quality, Clinical Research Associates, Central Complaint Handling Unit, Batch releasing Quality) and external partners (i.e. Contract Manufacturing Organizations,). 
  • Communicate batch related issues to management, EU Qualified Persons and the Swiss Responsible Person (FvP).

Your profile:

  • Bachelor's or Master's Degree in life sciences required, ideally in biotechnology, biology or pharmaceutical studies. Master's Degree in clinical research, clinical data or clinical analysis is also advantageous.
  • Minimum of 2-years' experience in GMP environment within the pharmaceutical business or comparable. 
  • Experience in batch record review is advantageous.
  • Excellent experience with Good Documentation Practices.
  • Demonstrated problem-solving skills, preferably with Six Sigma Tools 
  • Preferably SAP and MS Word/Excel experience.
  • English and German language - Proficiency at a business level is necessary.
  • Time-management skills to deliver by agreed deadlines, as well as high sense of responsibility.
  • Willing to drive issue resolution
  • Excellent communication, writing, and presentation skills.
  • Demonstrated ability to effectively collaborate and influence internal and external stakeholders.
  • Excellent analytical and problem-solving skills.
  • Excellent team player
Laura Feig

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